Epidemiology and Biometry, Carl von Ossietzky University of Oldenburg Faculty VI Medicine and Health Sciences, Oldenburg, Germany.
Big Data in Medicine, Carl von Ossietzky University of Oldenburg Faculty VI Medicine and Health Sciences, Oldenburg, Germany.
BMJ Open. 2023 Jul 17;13(7):e071273. doi: 10.1136/bmjopen-2022-071273.
Patients with neurological or neurosurgical disease can suffer from impaired cough, which may result in life-threatening retention of tracheobronchial secretions, atelectasis, pneumonia and finally death. Due to a lack of alternatives and pathophysiological plausibility, the application of mechanical insufflation-exsufflation (MI-E) has already become international standard care in neuromuscular disease and spinal cord injury although a lack of evidence for efficacy. High-quality studies to support the use of MI-E in neurological and neurosurgical patients during weaning from mechanical ventilation are missing. The goal of this exploratory study is to display the effect size of MI-E intervention on the duration of mechanical ventilation and additional outcomes.
One hundred adult patients with a cough deficiency or retention of secretion admitted to a neurological intensive care unit (ICU) are planned to be recruited for this randomised controlled trial. Patients are randomised 1:1 to receive either MI-E or best standard care. Observation will take place until discharge from the hospital, death or end of the study period. The primary endpoint of this trial is the duration of mechanical ventilation from randomisation until successful weaning. The outcome will be analysed with Kaplan-Meier estimation and competing risks analyses. Secondary endpoint is the proportion of patients with successful weaning. Further outcomes will include the incidence of hospital-acquired pneumonia, mortality, decannulation rate, length of stay on the ICU and the total score of the Glasgow Coma Scale.
The study was approved by the Medical Ethics Committee of the University of Oldenburg. The findings of this study will be submitted for publication in a peer-reviewed journal.
DRKS00020981.
患有神经或神经外科疾病的患者可能会出现咳嗽能力受损，这可能导致危及生命的气管支气管分泌物潴留、肺不张、肺炎，最终导致死亡。由于缺乏替代方法和病理生理学的合理性，机械通气-呼气（MI-E）的应用已经成为神经肌肉疾病和脊髓损伤的国际标准治疗方法，尽管缺乏疗效的证据。在从机械通气中脱机期间，支持 MI-E 在神经和神经外科患者中使用的高质量研究仍然缺乏。这项探索性研究的目的是展示 MI-E 干预对机械通气持续时间和其他结果的影响大小。
计划招募 100 名因咳嗽无力或分泌物潴留而入住神经重症监护病房（NICU）的成年患者进行这项随机对照试验。患者按 1:1 随机分为 MI-E 组或最佳标准护理组。观察将持续到出院、死亡或研究期结束。该试验的主要终点是从随机分组到成功脱机的机械通气持续时间。结果将采用 Kaplan-Meier 估计和竞争风险分析进行分析。次要终点是成功脱机的患者比例。进一步的结果将包括医院获得性肺炎的发生率、死亡率、拔管率、重症监护病房的住院时间和格拉斯哥昏迷量表的总评分。
该研究已获得奥尔登堡大学医学伦理委员会的批准。这项研究的结果将提交给同行评议的期刊发表。
DRKS00020981。
